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This article is from the NEJM Journal Watch Further Evidence of CAR-T Efficacy in Relapsed or Refractory Multiple Myeloma.
Further evidence shows that CAR-T therapy is effective for relapsed or refractory multiple myeloma.
Comment by Michael E.
Williams, After MD, ScM received cell therapy targeting B cell maturation antigen (BCMA), almost all patients were in remission
.
Research on chimeric antigen receptor T cell (CAR-T) therapy shows that the therapy has anti-tumor activity against relapsed/refractory multiple myeloma (R/R MM)
.
In the latest development of the therapy, a Phase 1b/2, open-label clinical trial of CAR-T ciltacabtagene autoleucel that targets BCMA, funded by a pharmaceutical manufacturer, evaluated patients with relapsed or refractory MM who have undergone extensive treatment The overall response rate (ORR) and toxicity after CAR-T treatment
.
113 patients were included in the study; 16 of them did not receive CAR-T infusion due to disease progression, withdrawal from the study, or death
.
There was no failure in the preparation of CAR-T cell products in this test
.
Ninety-seven patients (29 in stage 1b and 68 in stage 2) received the recommended stage 2 dose of 0.
75×106 cells/kg
.
In order to control the disease progression from blood cell apheresis and CAR-T preparation to the infusion period (median time, 29 days), most patients received over-treatment
.
During a median follow-up of 12.
4 months, the ORR was 97%, and 67% of patients achieved a strict complete remission
.
The patient's remission was rapid and improved over time; the 12-month progression-free survival rate was 77%
.
Almost all patients developed cytokine release syndrome (CRS); 4 cases were grade 3 to 4, and 1 case was grade 5 (death)
.
This study observed that 20 patients had neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS); 8 cases were grade 3 to 4, and 1 case was grade 5
.
Comment This study proves that this CAR-T targeting BMCA is very effective for R/R MM, and the US FDA is currently conducting priority review based on this clinical trial (CARTITUDE-1)
.
Another anti-BCMA CAR-T idecabtagene vicleucel was approved by the FDA in March 2021 for the treatment of R/R MM (NEJM JW Oncol Hematol Apr 2021 and N Engl J Med 2021; 384:705)
.
These drugs provide an important option for patients with disease progression after standard induction therapy, autologous stem cell transplantation, and maintenance therapy
.
Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): A phase 1b/2 open-label study.
Lancet 2021 Jul 24; 398:314.
(https://doi.
org/10.
1016/S0140-6736(21)00933-8) Related readings Important papers to help doctors understand and use the latest developments
.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.
Further evidence shows that CAR-T therapy is effective for relapsed or refractory multiple myeloma.
Comment by Michael E.
Williams, After MD, ScM received cell therapy targeting B cell maturation antigen (BCMA), almost all patients were in remission
.
Research on chimeric antigen receptor T cell (CAR-T) therapy shows that the therapy has anti-tumor activity against relapsed/refractory multiple myeloma (R/R MM)
.
In the latest development of the therapy, a Phase 1b/2, open-label clinical trial of CAR-T ciltacabtagene autoleucel that targets BCMA, funded by a pharmaceutical manufacturer, evaluated patients with relapsed or refractory MM who have undergone extensive treatment The overall response rate (ORR) and toxicity after CAR-T treatment
.
113 patients were included in the study; 16 of them did not receive CAR-T infusion due to disease progression, withdrawal from the study, or death
.
There was no failure in the preparation of CAR-T cell products in this test
.
Ninety-seven patients (29 in stage 1b and 68 in stage 2) received the recommended stage 2 dose of 0.
75×106 cells/kg
.
In order to control the disease progression from blood cell apheresis and CAR-T preparation to the infusion period (median time, 29 days), most patients received over-treatment
.
During a median follow-up of 12.
4 months, the ORR was 97%, and 67% of patients achieved a strict complete remission
.
The patient's remission was rapid and improved over time; the 12-month progression-free survival rate was 77%
.
Almost all patients developed cytokine release syndrome (CRS); 4 cases were grade 3 to 4, and 1 case was grade 5 (death)
.
This study observed that 20 patients had neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS); 8 cases were grade 3 to 4, and 1 case was grade 5
.
Comment This study proves that this CAR-T targeting BMCA is very effective for R/R MM, and the US FDA is currently conducting priority review based on this clinical trial (CARTITUDE-1)
.
Another anti-BCMA CAR-T idecabtagene vicleucel was approved by the FDA in March 2021 for the treatment of R/R MM (NEJM JW Oncol Hematol Apr 2021 and N Engl J Med 2021; 384:705)
.
These drugs provide an important option for patients with disease progression after standard induction therapy, autologous stem cell transplantation, and maintenance therapy
.
Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): A phase 1b/2 open-label study.
Lancet 2021 Jul 24; 398:314.
(https://doi.
org/10.
1016/S0140-6736(21)00933-8) Related readings Important papers to help doctors understand and use the latest developments
.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.